BACLOFEN

Post-LOE

baclofen

ANI Pharmaceuticals
ANDAORALSUSPENSION
Approved
Jun 2023
Lifecycle
Post-LOE
Competitive Pressure
30/100
Clinical Trials
9

Mechanism of Action

GABA A Agonists

Pharmacologic Class:

gamma-Aminobutyric Acid-ergic Agonist

Indications (7)

spasticity resulting from multiple sclerosisparticularly for the relief of flexor spasmsconcomitant painclonusmuscular rigiditythe treatment of skeletal muscle spasm resulting from rheumatic disordersmultiple sclerosis

Clinical Trials (5)

NCT03058237Phase 1Completed

A Phase 1 Bioavailability Study of Arbaclofen Placarbil Modified Release Formulations in Healthy Volunteers

Started Jan 2017
40 enrolled
Healthy Volunteers
NCT02511886Phase 2Completed

A Dose-Escalation Study to Determine the Maximum Tolerated Dose of Arbaclofen Placarbil in Subjects With Alcohol Use Disorder

Started Sep 2015
18 enrolled
Alcohol Use Disorder
NCT01051128Phase 3Withdrawn

Continuous Intrathecal Baclofen Infusion for Chronic Spasticity

Started Jan 2010
0
Spasticity
NCT00802035Phase 1Completed

ALK29-002: A Study of Baclofen Formulations in Healthy Adults

Started Nov 2008
NCT00516503Phase 3Completed

Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer

Started Feb 2008
208 enrolled
Chronic Myeloproliferative DisordersLeukemiaLymphoma+7 more
Company
ANI Pharmaceuticals
ANI Pharmaceuticals
BAUDETTE, MN
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers